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BIG PHYSICS, BIG QUESTIONS –

US court ruling on breast cancer genes a mixed blessing

By Peter Aldhous

YOU can’t patent a naturally occurring DNA sequence – but you can patent an altered product made from that sequence. That, in short, is the ruling handed down last week by the US Supreme Court on the validity of patents for the breast cancer genes BRCA1and BRCA2.

Widely billed as a decision on whether human genes can be patented in the US, the ruling actually applies to DNA from any species. Although it is a landmark decision, its impact on medicine may be less than anticipated. But the ruling could have far-reaching, unintended consequences for some sectors of the biotech industry. “They didn’t seem to grapple with the broader implications,” complains Hans Sauer of the Biotechnology Industry Organization in Washington DC.

The case was brought by a coalition of organisations against Myriad Genetics of Salt Lake City, Utah. It has used broad gene patents to operate a monopoly over testing for the two BRCA genes, which when mutated can cause inherited forms of breast cancer. Such a test led to movie star Angelina Jolie’s high-profile decision to have a double mastectomy to reduce her risk of developing the disease.

In a unanimous ruling, the Supreme Court decided that simply isolating a natural DNA sequence is not a patentable invention. However, it upheld Myriad Genetics’s claims on complementary DNA (cDNA) derived from the BRCA genes. These are sequences made in the lab from RNA – the template used to produce the proteins that genes code for. This cDNA lacks the non-coding “introns” found in the full sequence of a gene and is therefore not a product of nature – which is why the court ruled that it can be patented.

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As you don’t need to make cDNA to offer a diagnostic test, health campaigners hope that other companies will leap in, bringing down the cost of testing for BRCA1and BRCA2. One sticking point has come to light, though&colon; even with companies now promising to launch their own tests, Myriad may still be able to exert control over the market. In 2004, it stopped putting data on specific BRCA mutations in public databases, instead building its own private database to interpret test results. This means it will be able to provide more information than other firms on whether specific mutations are dangerous.

To counter this, a “Free the Data” campaign has been launched by non-profit health advocacy group Genetic Alliance, the University of California, San Francisco, and San Francisco-based genetic diagnostics company InVitae. They are appealing for people who have had BRCA tests to put their results into public databases.

Outside of BRCA testing, the ruling’s impact on medicine may be smaller. For the most part, broad patents on entire natural human gene sequences are a thing of the past – with the majority in existence due to expire soon.

Still, Sauer is concerned about the impact on companies working outside medicine that have been operating for 30 years under the assumption that a natural gene sequence can be patented. There are thousands of such patents in existence in sectors including agriculture and bioenergy.

He fears that some of these companies may find that their intellectual property has suddenly become worthless. “People have arranged their affairs around such patents,” he says.